WEST HAVEN, CONNECTICUT -- August 20, 2012 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that anti-influenza drug candidates under its FluCide™ program, when given orally, were nearly as effective as when administered as IV injections. Two different anti-influenza drug candidates were tested in Oral vs. IV comparison, and both of them showed similar results that indicated strong oral effectiveness. The results clearly demonstrated that oral administration of both of these FluCide drug candidates resulted in substantially superior animal protection compared to oseltamivir (Tamiflu®), a standard of care for influenza at present. The studies involved the same highly lethal animal model the Company has continued to use for its influenza drug development program.
The Company has previously said that the chemistries were modified in an attempt to make its drug candidates potentially available for oral administration.
One of the FluCide drug candidates, when administered orally, enabled the animals to survive as long as 347.4±4.6 hrs (14.5 days), and when given as an injectable, it allowed the animals to combat the lethal influenza infection for 376.8±7.5 hrs (15.7 days). Another drug candidate (with a different anti-viral ligand), when given orally, resulted in the animals surviving for as long as 301.3±5.2 hrs (12.6 days), and when given as a tail-vein injection, for 349.0±3.9 hrs (14.5 days). For comparison, untreated control animals died in 119.5±1 hrs (5 days), and oseltamivir (Tamiflu®) treated animals died within just 181.7±4.6 hrs (7.6 days).
The survival data clearly show that oral as well as IV administration of FluCide drug candidates was substantially superior to oseltamivir. In addition, they show that FluCide drug candidates when given orally had substantial efficacy, almost matching the effectiveness of the injectable form given at 0.3X of the oral dosage level.
No adverse effects were found, indicating that the FluCide dose could be increased further to achieve much greater levels of effectiveness.
“We can easily attain much greater antiviral effectiveness by increasing the oral dosage quantity,” said Anil R. Diwan, PhD, further explaining that “There are inherent limitations on the amount of drug that can be given by the IV route, which do not exist in oral administration.”
Tail-vein injections were given at 48 hr intervals starting at 24 hrs post-infection. Oral FluCide was given once daily. Oseltamivir was given twice daily (total 40mg/kg per day). The total quantity of FluCide drug given orally was 3.33 times that of the drug given as injectable, to adjust for expected reduction in the amount of drug going into circulation.
“We are seeing an extremely high level of oral effectiveness. We now know that FluCide can be developed as an oral drug for out-patient influenza,” said Eugene Seymour, MD, MPH, CEO of the Company, adding, “Many drugs are commercialized as oral drugs even if the oral dose needed is as high as five times the injectable dose.”
The Company is awaiting additional data from the studies and intends to release information as the data are analyzed and studied.
Nanoviricides, Inc. has been working on the development of an orally available nanoviricide for several years now. The essential chemistries were finally worked out during the CMC (Chemistry, Manufacturing, and Controls) studies for our current FluCide™ drug candidate. An initial feasibility study to determine whether a nanoviricide anti-influenza drug candidate would work when administered orally was undertaken perviously and had shown positive indications. The Company continued further development and has now completed a definitive animal model study to determine whether one of the FluCide anti-influenza drug candidates was effective when administered orally. The study was performed by KARD Scientific Inc. in the highly lethal influenza animal model as previously described.